Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Biological therapies, such as CpG 7909, use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: This randomized phase I/II trial is studying the side effects of CpG 7909 and to see how well it works in treating patients with cutaneous T-cell lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the safety of CpG 7909, in terms of adverse events, vital signs, and laboratory and clinical findings, in patients with stage IB-IVA cutaneous T-cell lymphoma. - Determine tumor response, as measured by the Composite Assessment of Index Lesion Disease Severity (CA), in patients treated with this drug. - Determine the tolerability of this drug in these patients. - Determine the immunopharmacodynamics of this drug in these patients. Secondary - Determine disease response, based on the Physician Global Assessment of Clinical Condition (PGA), in patients treated with this drug. - Determine duration of response, based on the CA and PGA, in patients treated with this drug. - Determine time to response in patients treated with this drug. - Determine time to progression in patients treated with this drug. OUTLINE: This is a phase I, open-label, multicenter, dose-escalation study followed by a randomized phase II study. - Phase I: Patients receive CpG 7909 subcutaneously (SC) once weekly on weeks 1-24 in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CpG 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients are randomized to receive 1 of 2 doses of CpG 7909, administered as in phase I. Patients are followed every 4 weeks. PROJECTED ACCRUAL: A total of 3-56 patients (3-36 for phase I and 20 [10 per treatment arm] for phase II) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed cutaneous T-cell lymphoma (CTCL) (limited to mycosis fungoides) - Stage IB-IVA disease - No other cutaneous lymphomas including, but not limited to, CD30-positive large-cell T-cell lymphoma, lymphomatoid papulosis, and pagetoid reticulosis - No visceral disease (stage IVB CTCL) - Must have received 1-3 prior systemic regimen(s), including psoralen ultraviolet light therapy (PUVA) - No CNS disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 4 months Hematopoietic - Neutrophil count ≥ 1,000/mm^3 - Platelet count > 100,000/mm^3 - WBC > 4,000/mm^3 - Hemoglobin ≥ 10 g/dL Hepatic - Bilirubin ≤ 1.5 mg/dL - SGOT or SGPT < 3 times upper limit of normal - PTT ≤ 40 seconds - No active hepatitis B or C Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - No unstable angina - No New York Heart Association class III-IV congestive heart failure - No myocardial infarction within the past 6 months - No uncontrolled atrial or ventricular cardiac arrhythmias - No other significant cardiovascular disease Immunologic - HIV negative - No autoimmune or antibody-mediated disease, including any of the following: - Systemic lupus erythematosus - Rheumatoid arthritis - Multiple sclerosis - Sjögren's syndrome - Autoimmune thrombocytopenia - Controlled thyroid disease allowed - Autoantibodies without clinical autoimmune disease allowed - No history of allergic reactions attributed to compounds of similar composition to CpG 7909 - No fever ≥ 38.2°C within the past 24 hours - No serious, symptomatic, significant local or systemic infection, including urinary tract infection Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 4 weeks after study participation - No suspected or confirmed poor compliance, mental instability, or prior or current alcohol or drug abuse that would preclude study participation or giving informed consent - No other medical history, including laboratory results, that would preclude study participation - No other malignancy within the past 5 years except basal cell or completely excised non-invasive squamous cell skin cancer or squamous cell carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent denileukin diftitox - No other concurrent immunotherapy, including but not limited to, interleukin-2, interferon (IFN) alfa, or IFN gamma Chemotherapy - At least 4 weeks since prior systemic chemotherapy for CTCL - No concurrent chemotherapy Endocrine therapy - No concurrent topical or systemic corticosteroids Radiotherapy - At least 4 weeks since prior electron beam therapy for CTCL - No concurrent radiotherapy Surgery - More than 6 months since prior coronary angioplasty Other - At least 2 weeks since prior topical therapy for CTCL - At least 3 weeks since prior phototherapy for CTCL - At least 4 weeks since prior photopheresis for CTCL - At least 4 weeks since other prior systemic therapy for CTCL - At least 4 weeks since prior daily systemic cholecalciferol (vitamin D) > 15,000 IU for CTCL - At least 4 weeks since prior oral retinoids, including bexarotene for CTCL - At least 4 weeks since prior investigational therapy for CTCL - No prior treatment for hepatitis B or C - More than 2 weeks since prior systemic antibiotics for CTCL - Patients receiving systemic antibiotics for CTCL must be on a stable regimen for at least 2 weeks before study entry - More than 30 days since prior participation in an investigational drug trial - No concurrent chloroquine phosphatase - No concurrent anticoagulant therapy except aspirin (≤ 325 mg/day) - No concurrent phototherapy - No concurrent photopheresis therapy - No concurrent bexarotene - No concurrent immunosuppressants - No other concurrent investigational drugs


NCT ID:

NCT00091208


Primary Contact:

Study Chair
Lauren C. Pinter-Brown, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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